Genetically Modified Organisms (GMOs)

Genetic Modification (GM) is the process of altering the genetic material of an organism by use of a method that does not occur in nature. Genetically Modified Organisms (GMOs) may be plants, animals or (most commonly) micro-organisms (including bacteria, viruses, parasites and fungi). Where the GMO is a micro-organism, it is typically referred to as a genetically modified micro-organism (GMM). A GMO that is a plant or an animal can be referred to as a larger GMO (LGMO).

Most GM work at QMUL is conducted within contained facilities like a laboratory, and there is no intention of the work to release the genetically modified organisms into the environment. The GMO Contained Use Regulations 2014 apply to such work, and there are specific responsibilities for duty holders (GMO Research Investigators and Heads of Schools / Institutes).

The key specific responsibilities for the duty holders are:

1. Carrying out an assessment of the risks to human health and the environment before any GM work begins.

   Use the template GMO Contained Use Risk Assessment Template [DOC 134KB] for work with GMMs, and Contained Use Risk Assessment_Larger GMOs assoc GMM [DOC 127KB] for work with plants or animals (see (7) below where this may be waived).

   Refer to guidance within the Genetic Modification Activities Policy [PDF 1,314KB] document, and
   the from the Scientific Advisory Committee on Genetic Modification (SACGM); particularly Part 2 for micro-organisms, Part 4 for plants, Part 5 for animals, Part 6 for clinical gene therapy trials.

   At QMUL, the Biological Safety Adviser (‘the competent adviser’) based in the Health and Safety Directorate is the first point of contact for advising on and reviewing GM risk assessments.

   Contact: Dr Mark Ariyanayagam (H&S Manager and Biological Safety Adviser); ext 8378 (Mon – Thurs), ext 2079 (most Fridays).

2. The appropriate containment measures (i.e. facility, procedures, and systems of work) are identified to provide a high level of safety between the GMO and humans / environment.

   For GMMs, a Containment Level is selected appropriate to the risks. For LGMOs, the appropriate containment measure is selected to control the identified risk.

   Refer to guidance within the  document and the Compendium of Guidance Part 3 (for micro-organisms) or Parts 4-6 for plants, animals, gene therapy clinical trials, as appropriate.

   Containment Level measures are summarised in QMUL inspection checklists; Containment Level 1 GMO and wild type organisms Inspection Checklist [DOC 39KB] Containment Level 1 GMO Clinical Setting Inspection Checklist Containment Level 2 Inspection Checklist [DOC 46KB] Containment Level 3 Inspection Checklist [DOC 46KB]

   Checklists for LGMOs – Containment Measures (plants), Containment Measures (animals) are available from the Biological Safety Adviser.

3. Ensuring peer review and classification into one of 4 risk based groups.

   At QMUL, all GM risk assessments are peer reviewed by the QMUL Genetic Modification Safety Committee (GMSC), and classified into one of 4 risk based groups for GMMs - GM Class 1 up to 4). Note – GM Class 4 is not permitted at QMUL, as QMUL does not have facilities or appropriate permits to conduct the highest risk work with GMMs.

   LGMO work is classified as less than, equivalent to, or of greater risk than the parental wild type organism by the GMSC.
   The QMUL GMSC peer reviews all GM risk assessments, classifies the risk level of the work as noted above, and monitors the effectiveness of GMO containment measures. The GMSC meets once an academic term (and ad hoc as required). All QMUL Schools and Institutes conducting GMO work have at least one representative member.

4. Notification of premises and projects involving higher risk work to the Regulator (under the Contained Use Regulations – the Health & Safety Executive, HSE), and payment of the notification fee (for GMM work classifying as Class 2 or above, or LGMO work posing greater risk than the parental wild type).

   At QMUL, this is coordinated through the Biological Safety Adviser. The HSE notification form CU2 is required to be completed for higher risk GM projects, and a notification fee payment made by the Research Investigator. (See also ‘QMUL guidance for payments without an invoice’).

   Connected Programs of Work - Where existing notifications have been made by QMUL and the new higher risk work forms part of a ‘coherent and integrated’ programme of work, it is possible to include the new work within the existing notification without payment of the fee. The Biological Safety Adviser will advise on this.

   All notifications are placed on a national Public Register; where sensitivity or confidentiality is required, a justified redacted notification will also need to be made. The Biological Safety Adviser will advise on this.

   Refer to guidance within the  document and to the Regulations.

5. The regulations require duty holders to notify any significant change affecting the risks associated with an ongoing notified contained use.

   ‘Significant’ means where the changes increase or present different risks compared to the originally notified work and lead to the user having to change the way they work (e.g. containment or control measures).

   The HSE notification form CU2 would need to be amended, and a significant change fee  payment made by the Research Investigator. At QMUL, this is coordinated through the Biological Safety Adviser.
   Refer to guidance within the  document, the Regulations and sector guidance.

6. Report accidents and incidents involving GMOs

   Accidents and incidents (e.g. near misses, dangerous occurrences) must be reported via the QMUL accident and incident reporting system. Where a significant higher risk accident or incident occurs telephone the Biological Safety Adviser or another member of the Health & Safety Directorate. Where an accident or incident is notifiable to the Regulator, the CU3 form will need to be completed and sent.

   Accidents and incidents involving GMOs also include non-intentional release to the environment.

7. Where low risk LGMOs are to be handled, generic environmental risk assessments are prepared for QMUL projects (to fulfil the requirements under the Environmental Protection Act 1990). These will need to be checked for adherence and attested by the Research Investigator and returned to the Biological Safety Adviser. If higher risks are likely, consult the Biological Safety Adviser.

   Environmental Risk Assessment - Environmental Risk Assessment_Low Risk Plant GMO [DOC 46KB], Environmental Risk Assessment Low Risk GMO Animals [DOC 42KB]

Training and Inspections
Under the Regulations, QMUL also has a duty to provide training for all GM workers, and monitor the effectiveness of the GMO control / containment measures.
GMO work specific training courses are provided by the Health & Safety Directorate – details of the course/s, schedule and booking details are HSD Training Courses page. Local training is also provided in QMUL Schools / Institutes on local safety procedures for GMO work.
Inspections of GMO facilities are conducted by the Biological Safety Adviser and GMSC in line with the Regulations, as a stand-alone inspection or as part of the peer review H&S inspections for each Faculty. Contact the Biological Safety Adviser for further details.

Deliberate Release of GMOs
Where deliberate intention to release GMOs into the environment is part of the proposed work (e.g. clinical gene therapy trials involving deliberate shedding of a GMO, plant crop trials), the GMO Deliberate Release Regulations 2002 would apply, and a specific notification would need to be made to the Regulator (DEFRA), with peer review conducted by a Government Advisory Group (ACRE). A QMUL local risk assessment template [DOC 48KB] is available to augment these notifications.

Contact the Biological Safety Adviser for further details and refer to the
QMUL Biological Safety Adviser: ext 8378 (Mon – Thurs), ext 2079 (most Fridays).
QMUL GMSC